FDA Adverse Event
Injury
Summary report: N
INTELECT TRANSPORT COMO
MDR report key: 2042009
·
Received March 31, 2011
Report
- Report Number
- 9616086-2011-00061
- Event Type
- Injury
- Date Received
- March 31, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 31, 2011
- Manufacturer
- DJ ORTHOPEDICS DE MEXICO
- Product Code
- IMG
- PMA / PMN Number
- K040285
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
USER FACILITY REPORTED "UNIT INVOLVED IN PT BURN." USER FACILITY REPORTED THAT UNIT BURNED A PT IN COMBO TREATMENT. THE USER MANUAL INCLUDES INSTRUCTIONS TO MOVE THE SOUND HEAD DURING THE THERAPY SESSION IN A CIRCULAR MOTION. NOT MOVING THE APPLICATOR AROUND DURING TREATMENT CAN RESULT IN INJURY SUCH AS THAT REPORTED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTELECT TRANSPORT COMO | COMBO ELECTROTHERAPY/ULTRASOUND | IMG | DJ ORTHOPEDICS DE MEXICO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |